Cancer Risk Assessment (eBook)

CHING-HUNG HSU, PhD, DABT, is a Vice President at TaiGen Biotechnology Co., Ltd. His professional experience includes positions at Merck & Co., Inc., the U.S. Environmental Protection Agency, and the California Environmental Protection Agency. Dr. Hsu earned his BS from the National Taiwan University and PhD from the Massachusetts Institute of Technology. He completed his postdoctoral training at the University of California at Berkeley. Dr. Hsu is board-certified in toxicology by the American Board of Toxicology. He has published numerous professional papers, book chapters, and technical reports. Dr. Hsu serves on the Editorial Board of two international peer-reviewed journals. TODD STEDEFORD, PhD, JD, DABT, is a Toxicology Advisor and In-house Counsel for a multinational specialty chemical manufacturer. Previously, he was a human health toxicologist with the U.S. Environmental Protection Agency and an adjunct scientist with the Polish Academy of Sciences. Dr. Stedeford is board-certified in toxicology by the American Board of Toxicology and licensed to practice law in the District of Columbia and the State of Louisiana. He has authored over eighty publications including peer-reviewed scientific articles, government health assessments, legal articles, and scientific and legal book chapters.

Contributors.

Preface.

SECTION I. CANCER RISK ASSESSMENT, SCIENCE POLICY, AND REGULATORY.

FRAMEWORKS.

1. Cancer Risk Assessment (Elizabeth L. Anderson, Kimberly Lowe, and Paul Turnham).

2. Science Policy and Cancer Risk Assessment (Gary E. Marchant).

3. Hazard and Risk Assessment of Chemical Carcinogenicity within a Regulatory Context (Henk Tennekes, Virginia A. Gretton, and Todd Stedeford).

4. Use of Cancer Risk Assessments in Determination of Regulatory Standards (Robert A. Howd and Anna M. Fan).

SECTION II. CANCER BIOLOGY AND TOXICOLOGY.

5. The Interplay of Cancer and Biology (James W. Holder).

6. Chemical Carcinogenesis: A Brief History of its Concepts with a Focus on Polycyclic Aromatic Hydrocarbons (Stephen Nesnow).

7. Hormesis and Cancer Risks: Issues and Resolution (Paolo F. Ricci and Edward J. Calabrese).

8. Thresholds for Genotoxic Carcinogens: Evidence from Mechanism-Based.

Carcinogenicity Studies (Shoji Fukushima, Min Wei, Anna Kakehashi, and Hideki Wanibuchi).

SECTION III. GENETIC TOXICOLOGY, TESTING GUIDELINES AND REGULATIONS, AND NOVEL ASSAYS.

9. Development of Genetic Toxicology Testing and its Incorporation into Regulatory Health Effects Test Requirements (Errol Zeiger).

10. Genetic Toxicology Testing Guidelines and Regulations (Lutz Müller and Hansjörg Martus).

11. In Vitro Genetox Assays (David Kirkland and David Gatehouse).

12. In Vivo Genetox Assays and Transgenic mutation models (Véronique Thybaud).

SECTION IV. ASSESSING THE HUMAN RELEVANCE OF CHEMICAL-INDUCED TUMORS.

13. Framework Analysis for Determining Mode of Action and Human Relevance (R. Julian Preston).

14. Experimental Animal Studies and Carcinogenicity (Bette Meek).

15. Cancer Epidemiology (Herman J. Gibb and Jessie P. Buckley).

16. Rodent Hepatocarcinogenesis (James E. Klaunig).

17. Mode of Action Analysis and Human Relevance of Liver Tumors Induced by PPAR-alpha Activation (J. Christopher Corton).

18. Alpha2u-globulin-Nephropathy and Chronic Progressive Nephropathy.

as Modes of Action for Renal Tubule Tumour Induction in Rats, and their Possible Interaction (Edward A. Lock and Gordon C. Hard).

19. Urinary Tract Calculi and Bladder Tumors (Samuel M. Cohen, Lora L. Arnold, and Shugo Suzuki).

SECTION V. METHODS FOR INFORMING CANCER RISK QUANTIFICATION.

20. Quantitative Structure-Activity Relationship (QSAR) Analysis of Genotoxic and Nongenotoxic carcinogens: A State-of-the-art overview (Yin-tak Woo and David Y. Lai).

21. Physiologically-Based Pharmacokinetic (PBPK) Models in Cancer Risk.

Assessment (Mathieu Valcke and Kannan Krishnan).

22. Omics and Its Role in Cancer Risk Assessment (Banalata Sen, Douglas C. Wolf, and Vicki Dellarco).

23. Computational Toxicology in Cancer Risk Assessment (Jerry Blancato).

SECTION VI. GENERAL APPROACHES FOR QUANTIFYING CANCER RISKS.

24. Linear Low-Dose Extrapolations (Michael Dourson and Lynne Haber).

25. Quantitative Cancer Risk Assessment of Nongenotoxic Carcinogens (Rafael Meza, Jihyoun Jeon, and Suresh H. Moolgavkar).

26. Nonlinear Low-Dose Extrapolations (Ari S. Lewis and Babara Beck).

27. Cancer Risk Assessment: More Uncertain than We Thought (Edmund A.C. Crouch).

28. Combining Neoplasms for Evaluation of Rodent Carcinogenesis Studies (Amy E. Brix, Jerry F. Hardisty, and Ernest E. McConnell).

29. Cancer Risk Based on an Individual Tumor Type or Summing of Tumors (Andrew G. Salmon and Lindsey A. Roth).

30. Exposure Reconstruction and Cancer Risk Estimate Derivation (Shannon H. Gaffney, Jennifer Sahmel, Kathryn D. Devlin, and Dennis J. Paustenbach).

Abbreviations and Acronyms.

Index.

"This book aims to inform and to provide interpretive guidance on
evaluating toxicological data and understanding the relevance of
such data to hazard evaluation and cancer risk estimation." (The
British Toxicology Society, 1 November 2011)